Recall Z-1644-2014— Gambro Renal Products, Incorporated

Name: FDA recall Z-1644-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-16

Class II · Terminated

Class II FDA medical device recall by Gambro Renal Products, Incorporated, initiated 2014-04-16, terminated 2015-12-08. It names one FDA 510(k) clearance: K060195. Product: Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.. Reason: The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013..

Recalling firm: Gambro Renal Products, Incorporated
Classification: Class II
Status: Terminated
Initiated: 2014-04-16
Terminated: 2015-12-08
Firm location: Lakewood, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K060195 — GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USEGambro Renal Products·cleared 2006-04-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.

Reason for recall

The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

Data sourced from openFDA. This site is unofficial and independent of the FDA.